1. Field of the Invention
This invention relates to an at least partially implantable system for rehabilitation of a hearing disorder which comprises at least one sensor (microphone) for picking up an acoustic signal and converting it into the corresponding electrical signals, an electronic signal processing unit for audio signal processing and amplification, an electrical power supply unit which supplies individual components of the system with current, and an output-side actoric stimulation arrangement.
2. Description of Related Art
The expression xe2x80x9chearing disorderxe2x80x9d is defined here as inner ear damage, combined inner ear and middle ear damage, and a temporary or permanent noise impression (tinnitus).
In recent years rehabilitation of sensorineural hearing disorders with partially implantable electronic systems has acquired major importance. In particular this applies to the group of patients in which hearing has completely failed due to accident, illness or other effects or is congenitally non-functional. If in these cases only the inner ear (cochlea) and not the neural auditory path which leads to the brain is affected, the remaining auditory nerve can be stimulated with electrical stimulation signals and thus a hearing impression can be produced which can lead to speech comprehension. In these so-called cochlear implants (CI) an array of stimulation electrodes which is controlled by an electronic system (electronic module) is inserted into the cochlea. This electronic module is encapsulated hermetically tightly and biocompatibly and is surgically embedded in the bony area behind the ear (mastoid). The electronic system, however, contains essentially only decoder and driver circuits for the stimulation electrodes. Acoustic sound reception, conversion of this acoustic signal into electrical signals and their further processing always take place externally in a so-called speech processor which is worn outside on the body. The speech processor converts the preprocessed signals coded accordingly onto a high frequency carrier signal which via inductive coupling is transmitted through the closed skin (transcutaneously) to the implant. The sound-receiving microphone always is located outside of the body and in most applications in a housing of a behind-the-ear hearing aid worn on the external ear and is connected to the speech processor by a cable. Such cochlear implant systems, their components and the principles of transcutaneous signal transmission are described, by way of example, in published European Patent Application EP 0 200 321 A2 and in U.S. Pat. Nos. 5,070,535, 4,441,210, 5,626,629, 5,545,219, 5,578,084, 5,800,475, 5,957,958 and 6,038,484. Processes of speech processing and coding in cochlear implants are described, for example, in published European Patent Application EP 0 823 188 A1, in European Patent 0 190 836 B1 and in U.S. Pat. Nos. 5,597,380, 5,271,397, 5,095,904, 5,601,617 and 5,603,726.
In addition to rehabilitation of congenitally deaf persons and those who have lost their hearing using cochlear implants, for some time there have been approaches to offer better rehabilitation than with conventional hearing aids to patients with a sensorineural hearing disorder which cannot be surgically corrected by using partially or totally implantable hearing aids. The principle consists in most embodiments in stimulating an ossicle of the middle ear or directly the inner ear via mechanical or hydromechanical stimulation and not via the amplified acoustic signal of a conventional hearing aid in which the amplified acoustic signal is supplied to the external auditory canal. The actuator stimulus of these electromechanical systems is accomplished with different physical transducer principles such as for example by electromagnetic and piezoelectric systems. The advantage of these devices is seen mainly in the sound quality which is improved compared to conventional hearing aids and for totally implanted systems in the fact that the hearing prosthesis is not visible. These partially and fully implantable electromechanical hearing aids are described, for example, by Yanigahara et al. xe2x80x9cImplantable Hearing Aidxe2x80x9d, Arch Otolaryngol Head Neck Surg-Vol 113, 1987, pp. 869-872; Suzuki et al. xe2x80x9cImplantation of Partially Implantable Middle Ear Implant and the Indicationxe2x80x9d, Advances in Audiology, Vol. 4, 160-166, Karger Basel, 1988; H. P. Zenner et al. xe2x80x9cFirst implantations of a totally implantable electronic hearing system for sensorineural hearing lossxe2x80x9d, in HNO Vol. 46, 1998, pp. 844-852; H. Leysieffer et al. xe2x80x9cA totally implantable hearing device for the treatment of sensorineural hearing loss: TICA LZ 3001xe2x80x9d, HNO Vol. 46, 1998, pp. 853-863; H. P. Zenner et al. xe2x80x9cActive electronic hearing implants for patients with conductive and sensorineural hearing lossxe2x80x94a new era of ear surgeryxe2x80x9d, HNO 45: 749-774; H. P. Zenner et al. xe2x80x9cTotally implantable hearing device for sensorineural hearing lossxe2x80x9d, The Lancet Vol. 352, No. 9142, page 1751; and are described in numerous patent documents, thus among others in published European Patent Applications EP 0 263 254 A1, in European Patents EP 0 400 630 B1 and EP 0 499 940 B1 and in U.S. Pat. Nos. 3,557,775, 3,712,962, 3,764,748, 5,411,467, 4,352,960, 4,988,333, 5,015,224, 5,015,225, 5,360,388, 5,772,575, 5,814,095, 5,951,601, 5,977,689 and 5,984,859. Here the insertion of an electromechanical transducer through an opening in the promontory for direct fluid stimulation in the inner ear is described in U.S. Pat. Nos. 5,772,575, 5,951,601, 5,977,689 and 5,984,859.
Many patients with inner ear damage also suffer from temporary or permanent noise impressions (tinnitus) which cannot be surgically corrected and against which up to date there are no approved drug treatments. Therefore so-called tinnitus maskers (WO-A 90/07251, published European Patent Application EP 0 537 385 A1, German Utility Model No. 296 16 956) are known. These devices are small, battery-driven devices which are worn like a hearing aid behind or in the ear and which, by means of artificial sounds which are emitted via for example a hearing aid speaker into the auditory canal, psychoacoustically mask the tinnitus and thus reduce the disturbing noise impression if possible to below the threshold of perception. The artificial sounds are often narrow-band noise (for example, tierce noise) which can be adjusted in its spectral position and its loudness level via a programming device to enable adaptation to the individual tinnitus situation as optimum as possible. In addition, there since recently exists the so-called retraining method in which by combination of a mental training program and presentation of broadband sound (noise) near the auditory threshold in quiet the perceptibility of the tinnitus is likewise supposed to be largely suppressed (H. Knoer xe2x80x9cTinnitus retraining therapy and hearing acousticsxe2x80x9d journal xe2x80x9cHoerakustikxe2x80x9d February 1997, pages 26 and 27). These devices are also called xe2x80x9cnoisersxe2x80x9d.
In the two aforementioned methods for hardware treatment of tinnitus, hearing aid-like, technical devices must be carried visibly outside on the body in the area of the ear; they stigmatize the wearer and therefore are not willingly worn.
U.S. Pat. No. 5,795,287 describes an implantable tinnitus masker with direct drive of the middle ear for example via an electromechanical transducer coupled to the ossicular chain. This directly coupled transducer can preferably be a so-called xe2x80x9cFloating Mass Transducerxe2x80x9d (FMT). This FMT corresponds to the transducer for implantable hearing aids which is described in U.S. Pat. No. 5,624,376.
In commonly owned co-pending U.S. patent application Ser. Nos. 09/372,172 and 09/468,860 which are hereby incorporated by reference implantable systems for treatment of tinnitus by masking and/or noiser functions are described, in which the signal-processing electronic path of a partially or totally implantable hearing system is supplemented by corresponding electronic modules such that the signals necessary for tinnitus masking or noiser functions can be fed into the signal processing path of the hearing aid function and the pertinent signal parameters can be individually adapted by further electronic measures to the pathological requirements. This adaptability can be accomplished by the necessary setting data of the signal generation and feed electronics being stored or programmed by hardware and software in the same physical and logic data storage area of the implant system, and the feed of the masker or noiser signal into the audio path of the hearing implant can be controlled via the corresponding electronic actuators.
Depending on the desired function, implantable rehabilitation devices of the aforementioned type are comprised of several functional units, especially a sensor (microphone) which converts the incident airborne sound into an electrical signal, an electronic signal processing, amplification and implant control unit, an implantable electromechanical or electroacoustic transducer which converts the amplified and preprocessed sensor signals into mechanical or acoustic vibrations and sends them via suitable coupling mechanisms to the damaged middle and/or inner ear, or in the case of cochlear implants a cochlear stimulation electrode, and an electric power supply system which supplies the aforementioned modules. Furthermore, there can be an external unit which makes available electrical recharging energy to the implant when the implant-side power supply unit contains a rechargeable (secondary) battery. Especially advantageous devices and processes for charging of rechargeable implant batteries are described in commonly owned co-pending U.S. patent application Ser. No. 09/311,566 and in commonly owned U.S. Pat. No. 5,279,292 which are hereby incorporated by reference. Preferably there can also be a telemetry unit with which patient-specific, audiological data can be wirelessly transmitted bidirectionally or programmed in the implant and thus permanently stored, as was described by Leysieffer et al. in HNO Vol. 46, 1998, pp. 853-863.
Basically, in all these at least partially implantable systems the (audio) signal processing or signal generation and the implant control modules such as for example a controlled battery recharging system or a telemetry system for bidirectional transmission of for example variable, patient-specific parameters are accomplished on the implant-side by permanently fixed hardware units. This also applies when for signal processing or generation or for implant management digital signal processors or microcontrollers or microprocessors are used, regardless of whether they are built as so-called xe2x80x9chardwired logicxe2x80x9d, i.e. in xe2x80x9chardwiredxe2x80x9d logic architecture, or whether their operating programs are stored in read-only memory areas (for example, ROM) of the corresponding processors. These programs which are provided and are necessary for basic operation of the implant and for the intended functions are hereinafter called the operating program or the operating software. In the known implant systems this operating software is placed in the system during production for example by mask programming of processor storage areas and can no longer be changed after implantation.
In contrast thereto, patient-specific data such as for example audiological adaptation data or also variable implant system parameters (for example, a variable in one of the aforementioned software programs for control of battery recharging) herein are called operating parameters. In known totally implantable implant systems, after implantation these operating parameters can be transmitted transcutaneously, i.e. wirelessly through the closed skin, to the implant and thus can be changed.
The above described, at least partially implantable hearing systems for rehabilitation of a inner ear damage which are based on an output-side electromechanical transducer differ from conventional hearing aids essentially only in that the output-side acoustic stimulus (i.e. an amplified acoustic signal in front of the eardrum) is replaced by an amplified mechanical stimulus of the middle ear or inner ear. The acoustic stimulus of a conventional hearing aid ultimately leads to vibratory, i.e. mechanical stimulation of the inner ear, via mechanical stimulation of the eardrum and the subsequent middle ear. The requirements for effective audio signal preprocessing are fundamentally similar or the same. Furthermore, in both embodiments on the output side a localized vibratory stimulus is ultimately routed to the damaged inner ear (for example, an amplified mechanical vibration of the stapes in the oval window of the inner ear).
In cochlear implants exclusively electrical stimulation signals are used. After implantation of a CI for completely deaf patients generally training for rehabilitation of hearing is necessary since the artificial stimuli must be learned because fundamentally they do not correspond to the biologically proper form of stimulation of the inner ear. Conversely, this rehabilitation phase is eliminated after implantation of an electromechanical hearing system for the hard-of-hearing, since the mechanical stimulation form, as described above, is biologically suitable and, at least with respect to the basic function, ultimately corresponds to a large extent to treatment by a hearing aid, i.e. the stimulation at the entry to the inner ear is of vibratory nature.
Recently, partially and fully implantable hearing systems for rehabilitation of inner ear damage have been in clinical use. Depending on the physical principle of the output-side electromechanical transducer and especially its coupling type to the ossicle of the middle ear, it is to be seen that the attained results of improving speech comprehension can be very different. In addition, for many patients a sufficient loudness level cannot be reached. This aspect is spectrally very diverse; this can mean that for example at medium and high frequencies the generated loudness is sufficient, but not at low frequencies, or vice versa. Furthermore the spectral bandwidth which can be transmitted can be limited, thus for example for electromagnetic transducers to low and medium frequencies and for piezoelectric transducers to medium and high frequencies. In addition, nonlinear distortions which are especially pronounced in electromagnetic transducers can have an adverse effect on the resulting sound quality. The lack of loudness leads especially to the fact that the audiological indication range for implantation of an electromechanical hearing system can be very limited. This means that patients for example with sensorineural hearing loss of greater than 50 dB HL (hearing loss) in the low tone range can only be inadequately treated with a piezoelectric system. Conversely pronounced high tone losses can only be poorly treated with electromagnetic transducers.
For the aforementioned reasons, up to now implantable electromechanical systems cannot be employed for hearing disorders which approach deafness. Here cochlear implants with purely electrical stimulation of the inner ear may be considered which of course do not promise sound quality which for example would enable acceptable music transmission, but which rather are primarily designed for acquiring or restoring sufficient speech comprehension, as much as possible without lip reading. As a result of the electrical stimulation, as described, hearing losses which extend to complete deafness are possible in a spectrally wide audiological range.
Recently it has become scientifically known from CI implantations that even for incomplete deafness cochlear implants (CIs) can be successfully used when sufficient speech discrimination can no longer be achieved with a conventional hearing aid. Interestingly it was demonstrated that the important inner ear structures which enable residual acoustic hearing capacity can be maintained in part or largely stably over time when a CI electrode is inserted into the cochlea (S. Ruh et al.: xe2x80x9cCochlear implant for patients with residual hearingxe2x80x9d, Laryngo-Rhino-Otol. 76 (1997) 347-350; J. Mueller-Deile et al.: xe2x80x9cCochlear implant supply for non-deaf patients?xe2x80x9d Laryngo-Rhino-Otol. 77 (1998) 136-143; E. Lehnhardt: xe2x80x9cIntracochlear placement of cochlear implant electrodes in soft surgery techniquexe2x80x9d, HNO 41 (1993), 356-359). In the foreseeable future it certainly will be possible, in case of residual hearing capacity, to clinically place CI electrodes intracochlearly in a manner such that the remaining inner ear structures can be preserved over the long term and thus can continue to be stimulated in a biologically proper manner, i.e. vibrationally, and lead to a usable hearing impression.
The primary object of the present invention is to devise an at least partially implantable system for rehabilitation of a hearing disorder which is improved with respect to the known systems described above and which can be adapted especially effectively and flexibly to the individual pathological and audiological situation of the respective patient.
In accordance with the invention this object is achieved in that, in an at least partially implantable system for rehabilitation of a hearing disorder which comprises at least one sensor (microphone) for picking up the acoustic signal and for conversion thereof into corresponding electrical signals, an electronic signal processing unit for audio signal processing and amplification, an electrical power supply unit which supplies energy to individual components of the system, and an output-side actory stimulation arrangement, by the output-side stimulation arrangement having in combination an electromechanical transducer for mechanical stimulation of the middle ear or inner ear and an intracochlear, electrically acting stimulation electrode array having at least one stimulation electrode for electrical stimulation of the inner ear are provided.
The present invention at least partially circumvents, on the one hand, the aforementioned disadvantages of currently available implantable electromechanical hearing systems and on the other hand the drawbacks of cochlear implants, by using both types of stimulation, i.e. mechanical stimulation and electrical stimulation, in a single implant system, which two types of stimulation, depending on the individual pathological and audiological situation, can be applied patient-specifically. This system can be called a xe2x80x9cdualxe2x80x9d hearing implant. Furthermore, by the use of the hearing implant system of the present invention tinnitus which can be localized at least peripherally will be more effectively masked than with known conventional tinnitus maskers.
The output-side electromechanical transducer is preferably made hermetically sealed, and basically, can operate according to any known electromechanical transducer principle, and can be designed especially as an electromagnetic, electrodynamic, piezoelectric, magnetostrictive or dielectric (capacitive) transducer. The piezoelectric principle and the dielectric or capacitive principle are especially preferred. When using the piezoelectric transducer principle they are advantageously made using lead zirconate titanate ceramics or PVDF (polyvinylidene fluoride).
The output-side electromechanical transducer can be designed for direct mechanical coupling to the middle ear or for contactless, air gap-coupled coupling to the middle ear according to the electromagnetic transducer principle (permanent magnet attached to the ossicle) in order to transmit its vibratory output stimulus to an ossicle of the middle ear.
However, the electromechanical transducer can also be designed for direct hydromechanical coupling to the inner ear, wherein transmission of the vibratory output stimulus to the inner ear can be effected by direct mechanical stimulation of the lymphatic inner ear spaces via a passage through the oval, the round or an artificial cochlear window. This direct stimulation of the cochlea has the advantage that the occurrence of feedback, i.e., coupling of the output signal into the sensor (microphone), is prevented or largely reduced because the ossicle chain and thus the eardrum are not excited to vibrations or only are excited to a reduced degree. This is especially advantageous when an acoustic sensor (microphone function) is applied in the immediate vicinity of the eardrum, as is known from U.S. Pat. Nos. 5,814,095 and 5,999,632.
The output-side electromechanical transducer preferably has a transmission range from about 100 Hz to about 10 kHz and it is preferably tuned high, i.e., their its mechanical resonant frequency is at the upper end of the desired transmission frequency range, especially at about 8 kHz to about 10 kHz. This results in that the deflection frequency response of the transducer in the transmission range is largely free of resonances and in the case of voltage impression and use of piezoelectric transducers, is flat regardless of frequency. Thus, there is no ripple in the transmission range.
The signal processing unit, preferably, has a preprocessing arrangement for pre-amplification and/or filtering and for analog-digital (A/D) conversion of the acoustic sensor signals. It can, in particular, comprise anti-aliasing filters. If a plurality of acoustic sensors are used, preferably each of the acoustic sensors has an analog-digital converter connected to the output thereof.
In another embodiment of the invention, the signal processing unit can contain software modules which, parallel to operation of the hearing aid, enables masking of tinnitus. With this dual hearing implant system, tinnitus which can be at least peripherally localized can be masked more effectively than with known convention tinnitus maskers.
The signal processing unit advantageously has a digital signal processor for processing the A/D-converted acoustic sensor signals which have been optionally preprocessed by means of the preprocessing arrangement and/or for generation of digital signals for tinnitus masking, wherein at least one digital-analog converter is associated to the output-side stimulation arrangement and wherein preferable the output-side electromechanical transducer and the electrode(s) of the stimulation electrode array have its own digital-analog converter connected to the output thereof.
In another embodiment of the invention, the digital signal processor contains software modules which control the output-side electromechanical transducer and the stimulation electrode array such that the spectral, time, amplitude- and phase-referenced transducer or stimulation electrode signal properties are configured such that optimum hearing success is achieved in a manner specific to the patient.
The software modules can be designed to be static such that as a result of scientific findings they are stored once in a program storage of the digital signal processor and remain unchanged. But, if later, for example, due to more recent scientific findings, improved algorithms for speech signal conditioning and processing are available and are desired to be used, the entire implant or implant module which contains the corresponding signal processing unit must be replaced by a new unit with the altered operating software by invasive surgery on the patient. This surgery entails renewed medical risks for the patient and is very complex.
This problem can be solved in that, in another embodiment of the invention, a wireless, preferably PC-based telemetry means is provided for transmission of data between the implanted part of the system and an external unit, especially an external programming system, preferably a rewritable implantable storage arrangement being assigned to the signal processor for storage and retrieval of the operating program, and at least parts of the operating program can be replaced or changed by data transmitted from the external unit via the telemetry means. In this way, after implantation of the implantable system the operating software as such can be changed or even completely replaced, as is explained for otherwise known systems for rehabilitation of hearing disorders in commonly owned U.S. Pat. No. 6,198,971 which is hereby incorporated by reference.
In addition, the design of totally implantable systems preferably is such that in a manner known per se, after implantation also operating parameters, i.e., patient-specific data, for example, audiological adaption data, or variable implant system parameters (for example, a variable in a software program for control of battery recharging), can be transmitted transcutaneously, i.e. wirelessly through the closed skin, to the implant and can thus be changed. In such a case, the software modules are designed to be preferably dynamic, or in other words, adaptive, in order to rehabilitate the hearing disorder as optimally as possible. In particular, the software modules can be designed to be adaptive, and parameter matching can be done by training by the implant wearer and using other aids.
Furthermore, the signal processing electronics can contain a software module which achieves stimulation as optimum as possible based on an adaptive neural network. Training of this neural network can take place again by the implant wearer and/or using other external aids.
The storage arrangement for storage of operating parameters and the storage arrangement for storage and retrieval of the operating program can be implemented as storages independent of one another; however there can also be a single storage in which both the operating parameters and also operating programs can be filed.
This approach allows matching of the system to circumstances which can be detected only after implantation of the implantable system. Thus, for example, in an at least partially implantable hearing system for rehabilitation of a monaural or binaural inner ear disorder and of a tinnitus by mechanical stimulation of the inner ear, the sensoric (acoustic sensor or microphone) and actoric (output stimulator) biological interfaces are always dependent on anatomic, biological and neurophysiological circumstances, for example on the interindividual healing process. These interface parameters can also be individual, also especially time-variant. Thus, for example the transmission behavior of an implanted microphone can vary interindividually and individually as a result of being covered by tissue, and the transmission behavior of an electromechanical transducer which is coupled to the inner ear can vary in view of on different coupling qualities. These differences of interface parameters which cannot be eliminated or reduced in the devices known from the prior art even by replacing the implant can now be optimized by changing or improving the signal processing of the implant.
In an at least partially implantable hearing system, it can be advisable or become necessary to implement signal processing algorithms which have been improved after implantation. Especially the following should be mentioned here.
speech analysis processes (for example, optimization of a fast Fourier transform (FFT))
static or adaptive noise detection processes
static or adaptive noise suppression processes
processes for optimization of the signal to noise ratio within the system
optimized signal processing strategies in progressive hearing disorder
output level-limiting processes for protection of the patient in case of implant malfunctions or external faulty programming
processes of preprocessing of several sensor (microphone) signals, especially for binaural positioning of the sensors
processes for binaural processing of two or more sensor signals in binaural sensor positioning, for example optimization of spacial hearing or spacial orientation
phase or group delay time optimization in binaural signal processing
processes for optimized driving of the output stimulators, especially for binaural positioning of the stimulators.
Among others, the following signal processing algorithms can be implemented with this system even after implantation:
processes for feedback suppression or reduction
processes for optimization of the operating behavior of the output transducer(s) (for example, optimization of the frequency response and phase response, improvement of the impulse response)
speech signal compression processes for sensorineural hearing loss
signal processing methods for recruitment compensation in sensorineural hearing loss
Furthermore, in implant systems with a secondary power supply unit, i.e., a rechargeable battery system, but also in systems with primary battery supply, it can be assumed that these electrical power storages will enable longer and longer service lives, and thus, increasing residence times in the patients as technology advances. It can be assumed that fundamental and applied research for signal processing algorithms will make rapid progress. The necessity or the desire for operating software adaptation and modification will therefore presumably take place before the service life of the implanted power source expires. The system described here allows this adaptation of the operating programs of the implant even when it has already been implanted.
Preferably, there can furthermore be provided a buffer storage arrangement in which data transmitted from the external unit via the telemetry means can be buffered before being relayed to the signal processor. In this way, the transmission process from the external unit to the implanted system can be terminated before the data transmitted via the telemetry means are relayed to the signal processor.
Furthermore, there can be provided checking logic which checks the data stored in the buffer storage arrangement before relaying the data to the signal processor. There can be provided a microprocessor module, especially a microcontroller, for control of the A/D-converters and/or the D/A converters and/or the signal processor within the implant via a data bus, preferably the checking logic and the buffer storage arrangement being implemented in the microprocessor module, and wherein also program parts or entire software modules can be transferred via the data bus and the telemetry means between the outside world, the microprocessor module and the signal processor.
An implantable storage arrangement for storing the working program for the microprocessor module is preferably assigned to the microprocessor module, and at least parts of the working program for the microprocessor module can be changed or replaced by data transmitted from the external unit via the telemetry means.
In another embodiment of the invention, at least two storage areas for storage and retrieval of at least the operating program of the signal processor may be provided. This contributes to the reliability of the system, in that due to the multiple presence of a storage area which contains the operating program(s), for example, after transmission from the exterior or when the implant is turned on, checking for the absence of faults in the software can be done.
Analogously to the above, the buffer storage arrangement can also comprise at least two storage areas for storage and retrieval of data transferred from the external unit via the telemetry means, so that after data transmission from the external unit still in the area of the buffer storage the absence of errors in the transferred data can be checked. The storage areas can be designed for example for complementary filing of the data transferred from the external unit. At least one of the storage areas of the buffer storage arrangement however can also be designed to store only part of the data transferred from the external unit, wherein in this case the absence of errors in the transferred data is checked in sections.
Furthermore, to ensure that in case of transmission errors, a new transmission process can be started, a preprogrammed read-only memory area which cannot be overwritten can be assigned to the signal processor, in which ROM area the instructions and parameters necessary for xe2x80x9cminimum operationxe2x80x9d of the system are stored, for example, instructions which after a xe2x80x9csystem crashxe2x80x9d ensure at least error-free operation of the telemetry means for receiving an operating program and instructions for its storage in the control logic.
As already mentioned, the telemetry means is advantageously designed not only for reception of operating programs from the external unit but also for transfer of operating parameters between the implantable part of the system and the external unit such that on the one hand such parameters (for example the volume) can be adjusted by a physician, a hearing aid acoustics specialist or the wearer of the system himself, and on the other hand, the system can also transfer the parameters to the external unit, for example, to check the status of the system.
A totally implantable hearing system of the aforementioned type can have, on the implant side, in addition to the actoric stimulation arrangement and the signal processing unit, at least one implantable acoustic sensor and a rechargeable electrical storage element, and in this case, a wireless transcutaneous charging device can be provided for charging of the storage element. It goes without saying that, for power supply, there can also be provided a primary cell or another power supply unit which does not require transcutaneous recharging. This applies especially when it is considered that, in the near future, mainly by continuing development of processor technology a major reduction in power consumption for electronic signal processing can be expected so that for implantable hearing systems new forms of power supply will become usable in practice, for example, power supply which uses the Seebeck effect, as is described in U.S. Pat. No. 6,131,581. Preferably, there is also provided a wireless remote control for control of the implant functions by the implant wearer.
In case of a partially implantable hearing system, at least one acoustic sensor, an electronic signal processing arrangement, a power supply unit and a modulator/transmitter unit are contained in an external module which can be worn outside on the body, especially on the head over the implant. The implant comprises the output-side electromechanical transducer and the intracochlear stimulation electrode array, but is passive in terms of energy and receives its operating energy and transducer control data via the modulator/transmitter unit in the external module.
The described system can be designed to be monaural or binaural for the fully implantable design as well as for the partially implantable design. A binaural system for rehabilitation of a hearing disorder of both ears has two system units which each are assigned to one of the two ears. In doing so the two system units can be essentially identical to one another. However, one of the system units can also be designed as a master unit and the other system unit as a slave unit which is controlled by the master unit. The signal processing modules of the two system units can communicate with one another in any way, especially via a wired implantable line connection or via a wireless connection, preferably a bidirectional high frequency path, a ultrasonic path coupled by bone conduction, or a data transmission path which uses the electrical conductivity of the tissue of the implant wearer such that in both system units optimized binaural signal processing and transducer array control are achieved.
These and further objects, features and advantages of the present invention will become apparent from the following description when taken in connection with the accompanying drawings which, for purposes of illustration only, shows several embodiments in accordance with the present invention.